Acute Ischemic Stroke Program - eV3

Solitaire FR Revascularization Device Clinical Studies
Restore Flow
Unique design.
Fast flow restoration.
The Solitaire FR device’s self-expanding
design creates a simple, single-operator
procedure. 1
Retrieve Clot
Maximize clot retrieval.
Minimize procedure time.
Solitaire FR device with Parametric
Design provides multiple planes of
clot contact to enhance capture. 2
Revive
Neurological Tissue 4
Next generation technology.
Revolutionary clinical results.
Solitaire FR revascularization device is the
most effective 5 mechanical thrombectomy
device combining the ability to immediately
restore blood flow, administer medical
therapy and retrieve clot in patients
experiencing acute ischemic stroke.
REVASCULARIzATION RATE
VESSEL WALL
Clot
Solitaire FR
Device deployed
VESSEL WALL
Depiction of a 4x20 Solitaire FR Device in a vessel.
96.0%
68.5%
Retrospective Study (TICI≥2a) SWIFT (TIMI≥2)
Radial Force (N/mm)
mm 2
RADIAL FORCE 3
0.08
0.06
0.04
0.02
0
CELL AREA 3
0.12
0.1
0.08
0.06
0.04
0.02
Deployment Retrieval
0.71 1 1.5 2 2.5
Constrained Diameter (mm)
Based on an average of N=3 4x20 Solitaire FR Revascularization Devices
Maximized radial force when deployed within
occlusion to facilitate fast flow restoration.
0.095mm 2
81% of Area Maintained
0.1115mm 2
Based on an average of N=2 4x20 Solitaire 2.25mm
0.0
Cell Area in Constrained Tube.
FR Revascularization Devices.
2 3.0mm2 Parametric Design preserves cell-size over
varying vessel diameters which enhances clot
capture and retrieval.
3
3.5 4
FAST FLOW RESTORATION
Flow restoration to the MCA upon deployment of
the Solitaire FR device.
WALL APPOSITION 3
NEUROLOGICAL OUTCOMES MORTALITy RATE
54.6%
Retrospective Study
(mRS≤2)
36.0%
SWIFT
(mRS≤2)
58.2%
SWIFT
(Good Neurological
Outcomes)
Good neurological outcome defined as mRS ≤ 2, or equal to the prestroke
mRS if the prestroke mRS was higher than 2, or NI HSS score improvement
of 10 points or more.
Solitaire FR Revascularization
Device in a 3mm Vessel.
An optimal balance of navigability, wall-apposition,
and clot retention.
20.5%
17.2%
Retrospective Study SWIFT
Solitaire FR With Intention
For Thrombectomy (SWIFT) 7
Retrospective
Study 7
Principal Investigators (PI) J.L. Saver, U.S.A. N/A
Number of Patients
113
(58 Solitaire FR, 55 MERCI * )
Solitaire FR Thrombectomy for Acute
Revascularization (STAR) 7
V. Mendes Pereira, Switzerland
J. Gralla, Switzerland
reFerenCes
1. Design Specification: PS08-001F. 2. Covidien Testing Data: FD2601A. 3. FD2815: Competitive Device Test Plan---Flow Restoration Device. 4. SolitairetM FR Retrospective Study 5. The Solitaire FR
Revascularization Device is superior to the Merci Retrieval System* in achieving arterial recanalization of the occluded target vessel without any presence of symptomatic intracranial hemorrhage in the
Solitaire FR With Intention For Thrombectomy (SWIFT) Study SWIFT IDE # GO90082 FD2923. 6. Symptomatic Intracerebral Hemorrhage 7. Corelab reviewed 8. The CellotM balloon guide catheter may not
be available for distribution in your country.
INITIAL ANGIOGRAM AFTER INITIAL DEPLOYMENT
For general inquiries or to learn more about
Physician Workshops and Centers of Excellence,
please email stroke@covidien.com
141
200
(enrolling)
Baseline NIHSS 17.3 18 (8-30)
Recanalization Rate
(TIMI≥2)
Revascularization Rate
(TICI≥2b)
68.5% - N/A
- 85% Primary Endpoint
mRS≤2 at 90 days 36.3% 54.6% Secondary Endpoint
Mortality at 90 days 17.2% 20.5% N/A
Device Related Adverse Events 8.6% 0.7% N/A
SICH 6 1.7% 4% N/A
Solitaire FR With Intention For Thrombectomy (SWIFT): The purpose of this study is to demonstrate substantial equivalence of the Solitaire FR
revascularization device with a legally marketed device, Merci Retrieval System * .
Retrospective Study: The purpose of this study is to provide safety and efficacy data on the Solitaire FR device when used as a first choice device in
real practice in revascularization of patients with acute ischemic stroke.
Solitaire FR Thrombectomy for Acute Revascularization (STAR): The purpose of this study is to evaluate the safety and efficacy of the Solitaire FR device in subjects requiring mechanical thrombectomy when used to its Instructions For Use (IFU), in real life practice.
Case study images provided with permission by Prof. Andersson, Karolinska Hospital, Helsinki, Sweden.